The Laboratorian - Volume 3, Issue 3

Article Index

Editorial

My son’s favorite fruit is cantaloupe. I have often grabbed bites for myself as I washed, seeded, skinned, and diced. Perhaps, like me, the sweet, earthy scent evokes summer, bringing back memories of swim-enhanced appetite slaked by devouring the orange flesh straight from the rind, juice dripping toward your elbows. The recent food outbreak linked to cantaloupe stole some of my heedless joy in cantaloupe consumption. What if my son had been exposed to the bacteria that caused such wide-spread illness and even death? Fortunately, his window of danger is long past, along with cantaloupe season, but I know that I’m not the only one who will scrub next summer’s cantaloupes with added vigor. Read the article on “Investigating Listeriosis” to learn about the important work of public health laboratories as we work to solve food outbreaks.

As we begin the New Year, our Newborn Screening (NBS) and Blood Lead Screening programs continue their contributions to our on-going resolution: improve health and wellbeing in Texas. NBS is working to enhance the processes used in screening each baby born in Texas, and the Clinical Chemistry Group is working on internal and external improvements. You can read more about their progress in “Presenting NBS and Clinical Chemistry Process Improvements.”

Delve deeper into one of our improvement methodologies in the article on “Improving Laboratory Efficiency: Implementing Lean Six Sigma Principles.” This tool helps us overcome challenges in order to maintain high quality laboratory testing and improve customer and employee satisfaction.

In August 2011, the public was alarmed by reports of contaminated cantaloupes from Colorado. In early September, the Centers for Disease Control and Prevention (CDC) started epidemiological surveillance for Listeriosis. By November 1, 2011, the CDC reported a total of 139 people infected with one of four outbreak-associated strains of Listeriamonocytogenes. Of the 28 impacted states, 18 of the cases were from Texas. Although the DSHS Laboratory did not perform testing for this particular outbreak, it is an integral part of surveillance efforts for Listeriosis.

What is Listeriosis?

The CDC describes Listeriosis as a “serious infection usually caused by eating food contaminated with the bacterium Listeria monocytogenes.” The CDC also reports that there are about 1,600 cases of Listeria infection annually in the United States. The largest previous outbreak occurred in 2002, with 54 illnesses, eight deaths, and three fetal deaths in nine states. The cause was linked to contaminated turkey deli meat.

Transmission

The World Health Organization (WHO) lists several ways that Listeriosis can be contracted: “through the consumption of contaminated foods, particularly unpasteurized milk, soft cheeses, vegetables and prepared meat products such as pâté. Unlike most foodborne pathogens, Listeria multiplies readily in refrigerated foods that have been contaminated. Transmission is also possible from mother to fetus or from mother to child during birth.”

What is the nature of the disease?

Left undetected or untreated, the consequences of Listeriosis are severe. According to the WHO, “Listeriosis causes meningoencephalitis and/or septicemia in adults and newborn infants. In pregnant women, it causes fever and abortion. Newborn infants, pregnant women, the elderly and immunocompromised individuals are particularly susceptible to listeriosis. In others, the disease may be limited to a mild acute febrile episode. In pregnant women, transmission of infection to the fetus may lead to stillbirth, septicaemia at birth or neonatal meningitis."

Laboratory Consumer Microbiology Group

At the DSHS Laboratory, Listeriosis testing is done by the Consumer Microbiology Group, a division of the Microbiological Sciences Branch. Consumer Microbiology tests specimens primarily to determine if specimens meet quality standards and—in the case of outbreaks—participates in surveillance efforts. Consumer Microbiology also does testing on milk, water, shellfish, and food, as well as quality control testing. The food testing group is specifically tasked with detecting foodborne diseases, including Listeriosis, in submitted specimens.

Chris Malota, Senior Microbiologist for the Consumer Microbiology Group, said that his group tests specimens that may carry any

of six species of Listeria. One of these species is Listeria monocytogenes, which is considered pathogenic to humans. In 2011, Consumer Microbiology tested over 1,500 samples. These specimens included things like Mexican soft white cheese, ready to eat beef jerky, ham, and tamales.

In 2010, Consumer Microbiology tested large numbers of celery samples linked to a Listeria outbreak that was confined to Texas. Specimens can also take the form of environmental swabs from food surface contact areas in suspected facilities.

What tests are performed for Listeriosis?

Malota describes the two specific procedures used in the Laboratory to detect the presence of Listeria monocytogenes. The first procedure is known as the BAX ® PCR assay. This method is a rapid test that provides quick, preliminary results.

The other method, considered the gold standard in testing, is the culture procedure. This method uses the US Food and Drug Administration (FDA) approved Bacteriological Analytical Manual (BAM) for Detection and enumeration of Listeria monocytogenes. While the rapid test takes two days to obtain results, the BAM confirmatory method usually requires five days for negative specimens and ten days for positive specimens.

Surveillance

After testing, result reports are finalized and sent to submitters. As part of surveillance efforts, isolates are also sent to the DSHS Molecular Biology testing Laboratory for Pulsed Field Gel Electrophoresis (PFGE) analysis. Results are eventually matched through the National Molecular Subtyping Network for Foodborne Disease Surveillance or PulseNet.

The DSHS Laboratory presented two out of four posters at the State Health Services Council meeting in December 2011. Back by request—having been well-received during their presentation at the DSHS Quality Showcase Week—the posters represented the Texas Newborn Screening Performance Measures Project (TNSPMP) and the Public Health Performance Measures Project (PHPMP). Kathleen Adams of the Laboratory Clinical Chemistry Group (pictured at right) and Jill Wallace of the Laboratory Response Coordination Team (at left), presented and fielded questions from Council members.

In short, the three-year TNSPMP developed evidence-based performance for the pre- and post-analytical stages of Newborn Screening and the nine-month PHPMP identified laboratory-appropriate process and quality improvements and developed evidence-based performance measures for the pre-analytical stages of blood lead screening. You can read more about these projects in our July 2011 issue of The Laboratorian. The TNSPMP was finished prior to being featured in our July newsletter, but the PHPMP was just reaching its conclusion.

Based on the PHPMP’s identification of high-priority internal issues, a separate Continuous Quality Improvement (CQI) group was formed. The CQI group's current focus is to identify and minimize potential redundancies in Clinical Chemistry Group processes and paperwork. Clinical Chemistry Group Leadership is working with staff to accomplish this. After redundancies are minimized, the next issue will be addressed.

External improvements are also in progress. The current report card, provided to clinical submitters, was assessed and reformatted to increase readability, and the performance measures used in the report card were fully defined and their significance noted. The PHPMP team met with Information Technology (IT) staff to develop a project plan that will enable automatic generation of report cards from data in Harvest LIMS. This IT project is pending completion. After completion, feedback will be solicited from a subset of clinical submitters and any necessary changes implemented before it is rolled out to the rest of the 2,200 submitters. The goal of this project is for report cards to be available to submitters on a monthly basis through a secure web-based system. Clinical submitters can then use these report cards to improve their performance, thus reducing specimen unsatisfactory rates, transit times, and the number of specimens submitted with missing information.

Laboratory testing affects millions of people daily, and the importance of test results puts laboratories on the front line in patient care. Crucial tests include rabies, tuberculosis, newborn screening, and influenza. Laboratory employees must continue to strive for excellence in maintaining quality and consistency. This can be challenging. Public health laboratories nationwide are facing a reduction in resources—both fiscally with budget cuts as well as with shortages in staff. There is also an increase in the complexity of laboratory testing systems. This combination of challenges requires laboratory personnel to reassess their existing systems and practices. The question then arises: how do we maintain high quality laboratory testing while continuing to improve our customer and employee satisfaction?

Lean Six Sigma is a method for continuous quality improvements that combines concepts from two approaches: Lean operations and Six Sigma methodologies. It is a systematic approach that focuses on the reduction and elimination of waste and variations and imbalances in processes (Mayo Clinic). The basic premise is to reduce expenses by streamlining work processes. More specifically, Lean addresses the reduction of waste and cycle time, while Six Sigma focuses on customer acceptance (Bialek, 215). It can be applied within any organization that has a defined set of steps to achieve an end product. In a laboratory setting, the objective of the Lean approach is to enable delivery of quality patient laboratory results at the lowest possible cost, within the shortest time frame, while maintaining client satisfaction. Laboratories and health care facilities nationwide are increasingly implementing continuous quality improvements using Lean Six Sigma methods. For example, Mayo Medical Laboratories apply Lean methodologies as they continually work to optimize quality. The results achieved from applying these improvement actions include reducing batch sizes and reducing time for test set-up. These improvements affect both laboratorians and customers.

The history of Lean concepts can be traced back as early as 1913, when Henry Ford created a moving assembly line to create what he termed “flow production.” In the 1930s, Toyota perfected this system by creating more continuity. Toyota is now given credence for the success of Lean thinking (Mayo Clinic).

Six Sigma has roots that date back as far as the 1920’s. The work of Walter Shewhart and his student, Edward Deming, contributed to the concept of Statistical Process Control by making process flow charts—the first documented statistical method for evaluating processes and quality. Many years later, in 1986, Bill Smith, an employee of Motorola, approached his CEO with his “theory of latent defect.” This theory states that variation in manufacturing processes is the main culprit for defects and that these defects can be dramatically reduced by eliminating variation, which lessens waste. Eliminating the waste associated with defects saves money and increases customer satisfaction. Several years later, the term Six Sigma was coined (Today’s Engineer). Today it is a widely used methodology across businesses worldwide.

Implementing Lean process improvement methods is a journey that requires teamwork. When applied, results include increased quality, throughput, capacity, employee morale, and improved excellence in patient care. Lean Six Sigma will help guide the Laboratory in an effort to continually optimize both quality and employee and patient safety and care.

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